D-0568-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 3, 2024
- Initiation Date
- May 13, 2024
- Termination Date
- March 20, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,655 (30 count bottle), 34,149 (90 count bottle)
Product Description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025